The drug-eluting balloon market size was estimated to be US$ 762.56 million in 2021 and US$ XX million in 2023 and is expected to reach US$ 3663.64 million by 2031; it is estimated to record a CAGR of 17.5% till 2031. The introduction of DCB therapy is likely to remain a key drug-eluting balloon market trend.
Drug-eluting balloons represent a cutting-edge technology that has revolutionized the treatment of various chronic conditions, including cardiovascular and peripheral vascular diseases. This advancement in medical technology has simplified the management of obstructions within blood vessels. The increasing prevalence of conditions such as cardiovascular, peripheral vascular, and neurovascular diseases is a key driver behind the growth of the drug-eluting balloons market. For instance, there has been a significant surge in cardiovascular disease rates globally. Contributing factors include obesity, reduced physical activity, heightened stress levels, and changes in lifestyle, all of which have led to an uptick in cardiovascular disease occurrences. The European Society of Cardiology has identified atrial fibrillation as the most prevalent form of arrhythmia and it accounts for 0.28–2.6% of healthcare budgets in Europe. Furthermore, individuals with atrial fibrillation face a risk of stroke that is 5 times more than average, with atrial fibrillation being a contributing factor in 20–30% of all stroke incidents across Europe. A 2016 study by the same society revealed that around 7.6 million people aged 65 or older were affected by atrial fibrillation in the EU. Projections suggest a significant increase in these numbers, with an estimated 14.4 million people affected by 2060, marking an 89% increase. The prevalence of atrial fibrillation is also expected to rise from 7.8% in 2016 to 9.5% by 2060. Furthermore, a 2019 report by Biosense Webster titled “The Impact of Atrial Fibrillation in Asia Pacific” indicated that approximately 16 million people in the Asia Pacific had atrial fibrillation, with projections estimating a rise to nearly 72 million by 2050. This condition is notably more prevalent among the elderly and middle-aged populations, who are at higher risk of developing it. Therefore, drug-eluting balloons have played a crucial role in managing cardiovascular conditions. According to the Centers for Disease Control and Prevention, deep vein thrombosis (DVT) affects approximately 1-2 individuals per 1,000 annually in the US. With the rising incidents of vascular diseases, the demand for drug-eluting balloons is expected to grow significantly in the near future.
Global drug-eluting balloon market is segmented by region into North America, Asia Pacific, Europe, Middle East & Africa and South & Central America. The largest market for the drug-eluting balloons is held by the North American region. The key factor driving growth of the market include significantly rising vascular disease incidences, rising geriatric population, and growing product innovations. Whereas, the market is projected to have slow growth due to the stringent regulations for approval and high cost of procedures and products during the forecast period.
The drug-eluting balloons market includes both established market leaders and emerging companies. Among the leading players are Cook Medical, and Royal Philips (which is part of Koninklijke Philips N.V.), Medtronic plc, and Boston Scientific Corporation while numerous emerging companies are also making their mark in this space. These companies are actively involved in the ongoing development of diverse medical devices, continuously advancing their products to maintain and enhance their position in the global market.
For instance, in March 2024, Boston Scientific Corporation received U.S. Food and Drug Administration (FDA) approval for the AGENT Drug-Coated Balloon (DCB), for its use in the treatment of coronary in-stent restenosis (ISR) among patients suffering from coronary artery disease. ISR involves the blockage or narrowing of a vessel that has been previously stented, due to the buildup of plaque or scar tissue.
In June 2023, Surmodics, Inc. received approval from the U.S. Food and Drug Administration (FDA) for its SurVeil drug-coated balloon (DCB). This approval allows the SurVeil DCB to be marketed and sold within the US. It is designed for use by physicians in the percutaneous transluminal angioplasty, following proper vessel preparation, to treat new or recurring lesions up to 180 mm in length in the femoral and popliteal arteries, which have reference vessel diameters ranging from 4 mm to 7 mm.
The growth of the drug-eluting balloon market is being propelled by the introduction of innovative products from both established companies and new entrants. This is mainly attributed due to these products have expanded treatment options for physicians to treat cardiovascular conditions, peripheral artery diseases (PADs), and renal artery conditions, and so on.
Drug-eluting balloons show various advantages over the drug-eluting stents. The balloons are developed with long-awaited new transcatheter technologies that have shown promising factors to reduce high restenosis rates in peripheral artery diseases.
Therefore, the drug-eluting balloons are enabled with various developments that are not available with the drug-eluting stents. For instance, drug delivery through the balloon does not require polymer or stent to deliver drugs, and can reduce the vascular inflammatory response. The responses are further directly related to very late thrombosis events, whereas drug-eluting stents require polymer-based drug coatings.
The other advantages of the drug-eluting balloons include faster delivery of drug kinetics to the vessel, and the intima is within 30–60 seconds of balloon inflation. Whereas, the drug delivery through DES is slow and have controlled release of drug kinetics to block cell proliferation. Thus, the advantages of drug-eluting balloons over the drug-eluting stents are expected to increase the adoption of drug-eluting balloons in coming years.
Key segments that contributed to the derivation of the drug-eluting balloon market analysis are product type and end user.
The geographic scope of the drug-eluting balloon market report is mainly divided into five regions: Asia Pacific, Europe, North America, Middle East & Africa, and South & Central America.
North America has dominated the drug-eluting balloon Market. In the US, drug-eluting balloon market is projected to grow due to increasing incidences of peripheral artery diseases (PAD), growing FDA approvals, rising developments in the medical device industry, and others. The majority of the market growth is estimated due to the significantly increased incidences of peripheral artery diseases. The growing elderly population in the US is expected to increase the incidences of peripheral artery diseases. The Cleveland Clinic reports that heart valve disease impacts approximately 2.5% of the population in the US which encompasses conditions like valve regurgitation and stenosis. Over 2 million Americans are affected by a leaking heart valve. Asia Pacific is anticipated to grow with the highest CAGR in the coming years.
The regional trends and factors influencing the Drug-Eluting Balloon Market throughout the forecast period have been thoroughly explained by the analysts at Insight Partners. This section also discusses Drug-Eluting Balloon Market segments and geography across North America, Europe, Asia Pacific, Middle East and Africa, and South and Central America.
| Report Attribute | Details |
|---|---|
| Market size in 2021 | US$ 762.56 Million |
| Market Size by 2031 | US$ 3663.64 Million |
| Global CAGR (2023 - 2031) | 17.5% |
| Historical Data | 2021-2022 |
| Forecast period | 2023-2031 |
| Segments Covered |
By Product Type
|
| Regions and Countries Covered | North America
|
| Market leaders and key company profiles |
The Drug-Eluting Balloon Market market is growing rapidly, driven by increasing end-user demand due to factors such as evolving consumer preferences, technological advancements, and greater awareness of the product's benefits. As demand rises, businesses are expanding their offerings, innovating to meet consumer needs, and capitalizing on emerging trends, which further fuels market growth.
Market players density refers to the distribution of firms or companies operating within a particular market or industry. It indicates how many competitors (market players) are present in a given market space relative to its size or total market value.
Major Companies operating in the Drug-Eluting Balloon Market are:
Disclaimer: The companies listed above are not ranked in any particular order.
The drug-eluting balloon market is evaluated by gathering qualitative and quantitative data post primary and secondary research, which includes important corporate publications, association data, and databases. The following is a list of developments in the market for innovations, business expansion, and strategies:
The “Drug-Eluting Balloon Market Size and Forecast (2021–2031)” report provides a detailed analysis of the market covering the following areas: